5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

Sponsor

Sociedad de Lucha Contra el Cáncer del Ecuador (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05850377

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Condition or Disease	Intervention/Treatment	Phase
High Grade Glioma Glioma Glioma, Malignant Neoplasms, Neuroepithelial Neuroectodermal Tumors Photosensitizing Agents Neoplasm Malignant Brain Neoplasms, Adult, Malignant Central Nervous System Neoplasms Brain Tumor Tumour, Residual	Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan® Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

Detailed Description

The investigators are proposing a study that provides descriptive understanding of patients with High-Grade Gliomas in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

May 31, 2026

Anticipated Study Completion Date :

May 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Participants with known or suspected High-Grade Gliomas Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy	Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan® Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl. Other Names: Gliolan® Gleolan® Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA) During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.

Arm

Intervention/Treatment

Participants with known or suspected High-Grade Gliomas

Patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

Drug: 5-Aminolevulinic Acid (5-ALA) Gliolan®

Gliolan® is presented as a powder for oral solution in 60 ml colorless glass vials and is administered orally three hours (range 2-4 hours) before anaesthesia. One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-aminolevulinic acid hydrochloride (5-ALA HCl). The recommended dose is 20 mg 5-ALA HCl per kilogram body weight. One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

Other Names:

Gliolan®

Gleolan®

Procedure: Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

During the surgical exploration of the glioma, the neurosurgeon will attempt to identify the mass. The location of the tumor will be assessed using the blue-light filtered microscope. A biopsy of the fluorescent region will be taken to confirm the glioma subtype. The tumor will then be maximally resected.

Outcome Measures

Primary Outcome Measures

Disease-Free-Survival (PFS) [36 months]
Disease-Free-Survival calculates the time from treatment until the recurrence of disease or death after undergoing Fluorescence-Guided Surgery using 5-aminolevulinic acid (5-ALA)

Secondary Outcome Measures

Overall survival (OS) [36 months]
Overall survival is defined as time from initiation to death of any cause
Quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-Br) questionnaire [36 months]
The questionnaire provides an additional set of disease-specific questions pertaining to brain neoplasms. It consists of 46 items that refer to general issues of quality of life and specific to tumor location. Possible scores range from 0 to 108, with higher scores indicating better quality of life.
Average length of hospital stay (ALOS) [36 months]
The average length of stay in hospitals is often used as an indicator of efficiency. The ALOS refers to the average number of days that patients spend in hospital after surgery. It is calculated by dividing the number of bed-days by the number of discharges after procedure. Average length of stay range from 1 day to 4.5 days. Longer than average stays are usually a symptom of poor communication, quality of care, and effectiveness of treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age: 18 to 75 years (in pediatric cases will be included in the Central Nervous System (CNS) tumor board to make decisions on therapeutic management)
Patients with radiological suspicion (contrast uptake) of high-grade glioma (Grade III-IV)
Patients with high-grade and residual glioma following surgery for gross total resection
Patients with recurrent gliomas with reoperation criteria who previously received radiotherapy and chemotherapy
Patients for whom at least one postoperative magnetic resonance imaging (MRI) was available (up to 28 days after surgery and strictly before the start of radiotherapy)
Progressing, low-grade infiltrative gliomas with one of the following criteria:
Anaplastic foci with contrast uptake in MRI
Spectroscopy study in anaplastic suspected area with high malignancy criteria
Positive choline PET-CT (positron emission tomography / computer tomography)

Exclusion Criteria:

Tumors extending across midline
Basal ganglia tumor
Brainstem tumor
Multifocal gliomas
Suspected low-grade glioma without anaplastic foci
Neuraxial dissemination (ependymoma)
Karnofsky grade less than 60%
Infants or pregnant women
Acute or chronic types of porphyria
Non-acceptance of Fluorescence-Guided Surgery
Renal insufficiency confirmed by nephrological assessment
Hepatic impairment confirmed by gastroenterological assessment
Severe heart disease confirmed by cardiological assessment
Decompensated diabetes confirmed by endocrinological assessment
Known allergy to any contrast agent and/or previous history of anaphylactic shock
Hypersensitivity to the active substance or porphyrins
Asthma confirmed by pulmonological assessment
Pacemaker use